Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-29 @ 1:15 PM
Study NCT ID:
NCT00280761
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2006-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Adenocarcinoma of the Rectum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2006-01-19', 'studyFirstSubmitQcDate': '2006-01-19', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activation of NF-kappa B in response to treatment with external beam radiotherapy', 'timeFrame': '6-8 weeks after chemoradiation'}, {'measure': 'Correlation of NF-kappa B pathway activation with therapeutic outcomes', 'timeFrame': '6-8 weeks after chemoradiation'}], 'secondaryOutcomes': [{'measure': 'Downstream events induced by NF-kappa B activation', 'timeFrame': '12 months'}, {'measure': 'Global gene expression profiles at baseline and during chemoradiotherapy', 'timeFrame': 'prior to chemoradiation and 72 days post chemoradiation'}, {'measure': 'Correlation of changes in gene expression with patient outcomes', 'timeFrame': '72 days post chemoradiation'}, {'measure': 'Downstream events related to activation of p53 in response to treatment with radiotherapy', 'timeFrame': '72 post radiotherapy'}, {'measure': 'Correlation of p53 pathway-mediated events with clinical outcomes', 'timeFrame': '72 days post chemoradiation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the rectum', 'recurrent rectal cancer', 'stage II rectal cancer', 'stage III rectal cancer', 'stage IV rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.unclineberger.org/', 'label': 'web address for UNC Lineberger Comprehensive Cancer Center'}, {'url': 'http://www.cancer.gov/', 'label': 'web address for the National Cancer Institute (NCI)'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.\n\nPURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy.\n* Correlate NF-kappa B pathway activation (presumed to be anti-apoptotic in nature) with therapeutic outcomes (as measured by rate of pathologic complete response or downstaging by endoscopic ultrasound \\[EUS\\]).\n\nSecondary\n\n* Study downstream events induced by NF-kappa B activation.\n* Determine global gene expression profiles at baseline and during chemoradiotherapy.\n* Correlate changes in gene expression (compared with the baseline gene expression pattern) induced by a single dose of external beam radiotherapy with patient outcomes (as measured by pathologic response rate or downstaging by EUS).\n* Study downstream events related to activation of p53 in response to treatment with radiotherapy.\n* Correlate p53 pathway-mediated events with clinical outcomes.\n\nOUTLINE: Patients receive fluorouracil or capecitabine and undergo radiotherapy and surgery per standard care.\n\nPatients undergo tumor pinch biopsies at baseline and on days 1 and 2 of chemoradiotherapy. At the time of final surgical resection, a portion of the remaining rectal tumor will be liquid nitrogen banked. Patients not deemed surgical candidates are evaluated by transrectal ultrasound 6-8 weeks after completion of chemoradiotherapy to assess ultrasound response (downstaging versus no downstaging).\n\nTumor tissue samples are analyzed for NF-kappa B pathway activation; downstream events induced by NF-kappa B activation; changes in global gene expression; p53 function; apoptosis; and mRNA expression. Laboratory techniques used include tissue microarray, ELISA, RNase protection assay, fluorescence semi-quantitative PCR, TUNEL, IHC, and cDNA microarray analysis.\n\nIf normal tissue from biopsies is not available, whole blood may be collected at any point while patient remains on study for correlative analysis or research related to rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients (male, female, any ethnic background) with rectal (inferior margin of the tumor less than 15cms from anal verge by rigid sigmoidoscopy or below the level of S1-2 at operation) or sigmoid-rectal junction carcinomas confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample\n\n * Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery\n* Candidate for chemotherapy and radiotherapy, as defined by any of the following:\n\n * Tumor staged as T3 or N1-2 by rectal sonography\n * Tumor occupying \\> 40% of circumference of rectum\n * Tumor fixed to extra colonic structures as determined by digital rectal examination\n * Tumor \\< 5 cm from sphincter mechanism\n * Patient has inoperable disease and is being treated for palliation\n * Pelvic or anastomotic recurrences of previously resected rectal cancer\n* Planning to undergo chemotherapy and radiotherapy\n* No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection)\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00280761', 'briefTitle': 'Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum.', 'orgStudyIdInfo': {'id': 'LCCC 0216'}, 'secondaryIdInfos': [{'id': 'P30CA016086', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016086', 'type': 'NIH'}, {'id': 'CDR0000561688', 'type': 'OTHER', 'domain': 'PDQ number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Single Arm Trial', 'interventionNames': ['Drug: capecitabine', 'Drug: 5-fluorouracil', 'Procedure: Surgical Resection', 'Radiation: Radiation therapy']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist', 'armGroupLabels': ['1']}, {'name': '5-fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU'], 'description': 'Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist.', 'armGroupLabels': ['1']}, {'name': 'Surgical Resection', 'type': 'PROCEDURE', 'description': 'Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease).', 'armGroupLabels': ['1']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'otherNames': ['EBRT - External Beam Radiation Therapy'], 'description': 'Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Hanna Sanoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}